New Drug R&D

Ulipristal Acetate Tablets

Product Name: Ulipristal Acetate Tablets
Dosage Forms: Tablet
Strengths: 5 mg, 30 mg
Mechanism of Action:
5 mg: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect. Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
30 mg: The likely primary mechanism of action of ulipristal acetate for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.
Indications:
5 mg: It is indicated for pre-operative and intermittent treatment of moderate to severe symptoms of uterine
fibroids in adult women of reproductive age. 
30 mg: It is indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. 
Processing Number: CXHL1301244, CXHL1301245, CXHL1301246
Status: Has gotten the clinical trial permission (2016L01454, 2016L00023, 2016L00227) in January, 2016.
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